Cleared Traditional

EMERGENCY TRACHEOSTOMY KIT

K823872 · Omnicon Medical Corp. · Ear, Nose, Throat
Jan 1983
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K823872 is an FDA 510(k) clearance for the EMERGENCY TRACHEOSTOMY KIT, a Chamber, Acoustic (for Audiometric Testing) (Class I — General Controls, product code EWC), submitted by Omnicon Medical Corp. (Walker, US). The FDA issued a Cleared decision on January 21, 1983, 25 days after receiving the submission on December 27, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1060.

Submission Details

510(k) Number K823872 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1982
Decision Date January 21, 1983
Days to Decision 25 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code EWC — Chamber, Acoustic (for Audiometric Testing)
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.1060